Roche: CHMP recommends Ocrevus for paediatric relapsing MS (age 10+)

Regulatory update

The EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ocrevus (ocrelizumab) intravenous infusion for paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis. The U.S. Food and Drug Administration approved paediatric RMS use in May 2026; a final decision from the European Commission is expected in the near future.

OPERETTA 2 efficacy

The CHMP opinion is based on results from the Phase III OPERETTA 2 study. Ocrevus demonstrated non-inferiority to fingolimod for relapse control and reduced the risk of relapses by 48% compared with fingolimod. On MRI endpoints, Ocrevus reduced new or enlarging T2 lesions by 48% and gadolinium-enhancing active T1 lesions by 87% versus fingolimod.

Safety and tolerability

In children and adolescents, Ocrevus showed a safety profile consistent with that observed in adults; no patients stopped treatment due to side effects in OPERETTA 2. Roche reports an established adult safety record across more than 525,000 treated patients globally.

Patient population and product details

At least 40,000 children and adolescents live with multiple sclerosis worldwide, with roughly one-third in Europe. Ocrevus is a humanised monoclonal antibody targeting CD20-positive B cells. The IV regimen is an initial two 300 mg infusions two weeks apart followed by single 600 mg infusions every six months; a subcutaneous formulation is dosed as a 920 mg injection every six months.